Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...
Patent
1998-12-09
2000-06-06
Cook, Rebecca
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Radical -xh acid, or anhydride, acid halide or salt thereof...
514558, 514568, 514574, 514517, A61K 3119
Patent
active
060719613
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention pertains to antimicrobial compositions. Even more particularly the present invention concerns the use of antimicrobial compositions and the treatment of gastritis. Most particularly, the present invention concerns the use of food grade components in antimicrobial compositions for the treatment of gastritis.
2. Prior Art
It has been theorized that the gram negative bacterium H. pylori, previously referred to in the art as campylobacter pyloridis, is the cause of gastric and duodenal ulceration associated with chronic gastritis. Further, individuals infected with H. pylori have been observed to have an increased rate of gastric cancer. Therefore, a simple efficacious manner of eliminating this bacterium from the system would be more advantageous.
As is known, H. pylori is found at the epithelial cell junctions beneath the mucus layer of the stomach and is, therefore, thought to be effectively killed by systemic exposure to antibiotics as well as by direct luminal contact, thus, curing gastric and duodenal ulceration and decreasing the incidence of recurrence. Because of the observed and potential development of antibiotic resistant strains of H. pylori and the difficulty of penetrating the hydrophobic gastric mucus, coupled with the observed failure or ineffectiveness of single antibiotic therapy, the combination of 2 or 3 antibiotics is typically used.
Further, the administration of large doses of antibiotic exposes the patient to the risk of developing opportunistic infections with other antibiotics resistant organisms.
Yet, treatment other than with antibiotics for the elimination of H. pylori has not been readily perceived heretofore, because the elimination of H. pylori from the gastric mucosa is difficult for several reasons. First, it is difficult to prove that the bacteria is even present in the stomach. Therefore, it is equally difficult to monitor when it has been eliminated. Second, while H. pylori is normally killed by low pH, it has been observed to penetrate the mucus layer covering the gastric mucosa, which has a neutral pH. The gastric mucus acts as an unstirred layer and contains bicarbonate ions which buffer the layer, protecting the bacterium from the normal gastric, luminal pH of about 2 to about 4. Third, as noted above, a single antibiotic is frequently ineffective in eliminating H. pylori from the stomach.
As high as 10% of the population in the United States suffers from chronic inflammation of the stomach and duodenum in their lifetime. While nearly all patients with chronic gastritis have H. pylori infections, not all cases of H. pylori gastritis are associated with ulceration. Therefore, exposure of patients to the several and significant risks involved in triple antibiotic therapy is not warranted without sufficient testing to demonstrate the presence of H. pylori infection and associated ulceration.
As detailed hereinafter, the present invention provides a simple inexpensive way of treating H. pylori.
SUMMARY OF THE INVENTION
In a first aspect hereof and in accordance herewith there is provided a composition for arresting or eliminating H. pylori bacteria which, generally, comprises:
In a critical aspect hereof, each of the components used in the composition are "food grade" or have sufficiently low toxicity levels to permit ingestion or otherwise is enabled to be introduced internally into the body of a user.
Preferably, the composition hereof has a pH ranging from about 1 to about 5.
In another facet hereof, there is provided a method for arresting or eliminating H. pylori bacteria from the body of the user which, generally, comprises contacting the H. pylori bacteria with the antimicrobial composition hereof. Contacting the bacterium with the composition is achieved by ingesting or otherwise introducing the composition into the digestive tract of the user.
The composition may be ingested either as a liquid, as a gelatinized capsule or may be introduced by any other suitable medium which permits the
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patent: 5460833 (1995-10-01), Andrews et al.
Jain et al, Pharmazie, 46, pp 798-800, 1991.
Walsh et al N. Eng. J Med 333(15) pp 984-991, Oct. 12, 1995.
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